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Interscalene Block With and Without Liposomal Bupivacaine in Shoulder Surgery

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ClinicalTrials.gov Identifier: NCT03728946
Recruitment Status : Completed
First Posted : November 2, 2018
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Paul Sethi, Orthopaedic & Neurosurgery Specialists

Tracking Information
First Submitted Date  ICMJE October 31, 2018
First Posted Date  ICMJE November 2, 2018
Last Update Posted Date March 24, 2020
Actual Study Start Date  ICMJE November 21, 2018
Actual Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2018)
Opiate Consumption [ Time Frame: Post-operative days 1-14 ]
Total amount of narcotics consumed during the postoperative period, measured in morphine equivalents (OME)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2020)
  • VAS Pain Scores [ Time Frame: Post operative days 1-14 ]
    A standardized measure of subjective pain on a scale of 0 to 10, from zero pain to excruciating pain, respectively
  • Likert Pain Satisfaction Rating [ Time Frame: Post operative days 1-14 ]
    A standardized measure of patient satisfaction with pain management from 1 (very unsatisfied) to 5 (very satisfied)
Original Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2018)
VAS Pain Scores [ Time Frame: Post operative days 1-14 ]
A standardized measure of subjective pain on a scale of 0 to 10, from zero pain to excruciating pain, respectively
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Interscalene Block With and Without Liposomal Bupivacaine in Shoulder Surgery
Official Title  ICMJE Interscalene Block With and Without Liposomal Bupivacaine in Shoulder Surgery
Brief Summary The purpose of this study is to examine the difference in perioperative pain after shoulder surgery with a standard bupivacaine nerve block compared to liposomal bupivacaine enhanced nerve block alone in TSA and ARCR. Data will be compared using VAS scores and opiate consumption between the two groups. The hypothesis of this study is that an interscalene nerve block with liposomal bupivacaine will decrease both postoperative VAS pain scores and total narcotic consumption when compared to a standard bupivacaine interscalene nerve block alone.
Detailed Description

Arthroscopic rotator cuff repair (ARCR) and shoulder arthroplasty (TSA) provide excellent clinical outcomes but are often associated with significant postoperative pain, frequently managed with oral opioid medication. Orthopedic surgeons prescribe approximately 32 unused pills per shoulder surgery and are the third largest prescribers of opiates in the USA. It is incumbent upon the orthopedic community to identify postoperative pain management methods which reduce the need for narcotic medication following shoulder procedures as a means to mitigate the impact of orthopedic procedures on this epidemic.

The use of intraoperative local and regional anesthesia or field blocks, in conjunction with multimodal pharmacological strategies, is an accepted approach for managing surgical pain and reducing opiate use but requires peer reviewed protocols to gain wider acceptance.

Interscalene nerve block with bupivacaine remains a gold standard for peri-operative analgesia, but is associated with significant rebound pain due to the short duration of the local anesthetics. Recent studies have demonstrated that the addition of a liposomal bupivacaine field block may lower pain and enhance patient satisfaction throughout the first postoperative week. Liposomal bupivacaine has recently received FDA approval for ISB, but the data regarding its efficacy in nerve blocks is sparse.

The purpose of this pilot study is to determine if liposomal bupivacaine-enhanced interscalene nerve blocks can be used to improve peri-operative pain control methods, limit narcotic use, and provide appropriate postoperative analgesia compared to standard bupivacaine blocks. Primary and secondary outcome measures will be collected as number of opiates taken and self-reported VAS pain scores over a 14 day postoperative period, respectively.

The hypothesis of this study is that an interscalene nerve block with liposomal bupivacaine will decrease both postoperative VAS pain scores and total narcotic consumption when compared to a standard bupivacaine interscalene nerve block alone.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Rotator Cuff Tear
  • Postoperative Pain
Intervention  ICMJE Drug: Liposomal Bupivacaine
Addition of 15mL of liposomal bupivacaine to 15mL of standard nerve block anesthetic solution containing 0.5% bupivacaine and 4mg of decadron
Other Name: EXPAREL
Study Arms  ICMJE
  • Experimental: Liposomal Bupivacaine Interscalene Block
    Liposomal bupivacaine anesthetic will be administered as an interscalene block during rotator cuff repair surgery and total shoulder arthroplasty.
    Intervention: Drug: Liposomal Bupivacaine
  • No Intervention: Bupivacaine Interscalene Block
    Bupivacaine anesthetic will be administered as an interscalene block during rotator cuff repair surgery and total shoulder arthroplasty.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 31, 2018)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 1, 2020
Actual Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients over 18 undergoing rotator cuff repair or total shoulder arthroplasty

Exclusion Criteria:

  • Pregnant
  • Documented drug of alcohol abuse
  • Active narcotic use prior to surgery
  • Neurological deficit
  • Allergy to amide anesthetics
  • Not cleared by primary care physician
  • Hydrocodone or oxycodone intolerance
  • Enrollment in another clinical trial or past cognitive or mental health status that interferes with study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03728946
Other Study ID Numbers  ICMJE 2018016
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Paul Sethi, Orthopaedic & Neurosurgery Specialists
Study Sponsor  ICMJE Orthopaedic & Neurosurgery Specialists
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Orthopaedic & Neurosurgery Specialists
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP